Whistleblowers shine light on shady Big Pharma behavior.
This story has a long timeline. It starts with the mumps vaccine that Merck’s eminent vaccinologist Maurice Hilleman, MD, came up with using a strain he developed from his five year old daughter—commonly referred to as the “Jeryl Lynn” strain—that has been manufactured by Merck since 1967.
In essence what transpired is the vaccine virus was “passaged” over the years through various growth medium or animal cells that caused the vaccine to lose its potency—let’s say ‘watered down’—and it became non-effective against the “wild” mumps virus. However, Merck had contended its MMRII vaccine was 95 percent effective (efficiency or efficacy rate) since at least the year 2000. The compliant charges Merck listed that false information on the vaccine package inserts which the U.S. CDC, FDA, and the National Vaccine Program relied upon as accurate information to promote to health agencies. That was not scientifically accurate nor was Merck able to produce that 95 percent effectiveness rate according to the accepted practices the CDC and FDA relied upon for vaccines to be certified. However, Merck never ‘fessed up that it was selling bum dope information and defective MMRII vaccines.
What happened next is what in accounting parlance is called “cooking the books.” Let’s say Merck apparently ‘cooked the science’. Still, two MDs who worked on the project were conscience struck about all the shenanigans that Merck scientists came up with in trying to reach the 95 percent efficacy rate that allowed Merck to maintain its MMRII vaccine monopoly in the United States.
However, other Merck vaccines contained the ‘watered down’ mumps vaccine. They included the quadravalent vaccine ProQuad, and the trivalent MMRVaxpro Merck sold to European markets. In 2005 the FDA recalled Merck’s ProQuad.
The ‘science’ that Merck managers came up with was to use animal (rabbit) antibodies that increased the efficacy rate to 100 percent. That sent up red flags since pre-vaccine and post-vaccine blood tests had to be taken. That’s when the normal 10 percent positive in pre-vaccine blood test results shot to 80 percent positive, a ‘perfect storm’ event indicating mischievous manipulation of scientific protocols, plus something that would not occur naturally. That led to more falsification that two whistleblowers presented to Merck officials who, in turn, told them they would be jailed if they reported to the FDA what was going on. Also, the whistleblowers were reminded of the huge bonuses that would be paid to them when the FDA approved Merck’s paperwork for certification.
Long story short, FDA finally was able to sort out the mess with the help of the whistleblowers who became plaintiffs along with the United States of America ex rel., in the original complaint [Civil Action No.10-4374, U.S. District Court for the Eastern District of Pennsylvania] filed August 27, 2010.
What I would like to concentrate on are the annotations I made while reading the amended complaint because I think they will hit a few home runs for vaccine safety advocates.
According to both the original and amended [filed April 27, 2012] complaints, a jury trial is requested. Treble damages are requested since the U.S. government estimates it paid Merck more than $700 Million for the MMRII vaccine administered to children in the USA. Based upon those figures, damages alone would amount to about $2.25 Billion. Then penalties for each violation have to be added on, plus the court awarding all legal costs the two former Merck employee whistleblowers incurred filling the lawsuit, in addition to certain interest amounts the court will allow.
All that does absolutely nothing to help the millions of infants and children who also had a fraud perpetrated upon them and from which they have suffered losses either as adverse events and/or contraction of mumps—all while believing they were protected—the intent for such vaccinations. Since Merck apparently produced pseudo science with resulting vaccine package inserts to match, the CDC, FDA, federal, state and local health agencies, MDs, pediatricians, nurses and the media believed such poppycock or pseudo science.
This whistleblower court case exonerates vaccine safety advocates of any conspiracy theories regarding the safety and efficacy of vaccines, I do believe. Furthermore, who is to say the Merck mumps vaccine ‘sleight of science’ is an anomaly. More whistleblowers need to come forth because this writer feels the Merck mumps vaccine fraud just may be the tip of the every-growing-science-manipulated, fraud iceberg. There probably is more to that than meets the scientific eye, and FDA needs to get on the stick about not relying upon vaccine makers to do the science.
One question that pops up regarding mumps outbreaks that could not be figured out seemingly parallels what’s happening with pertussis (whooping cough) and measles outbreaks that are being blamed on non-vaccinated children. I respectfully suggest that CDC and FDA do some housecleaning on vaccine-manufacturers’ science by having independent laboratories confirm efficacy rates.
Something that I think needs pointing out is the CDC and FDA must ask each vaccine maker pointed questions about all vaccine efficacy rates since Merck may not be the only manufacturer to use the rabbit antibodies trick, a genuine scientific fraud.
Part of the 55-page amended complaint deals with Merck’s false representation through package inserts which, after reading the shenanigans that went on—and probably go on to prove a product—no vaccine package insert should be regarded as factual, in my opinion.
Scientists apparently are not beyond painting white mice black or black mice white to prove what’s needed to be proven to get a pharmaceutical to market.
The original 95 percent efficacy rate for Merck’s mumps vaccine was based upon the 1967 filing for governmental approval. Can you imagine that? And they call vaccine safety advocates liars!
All the above leads one to ask if there is anything else Merck falsifies about vaccines.
Do other pharmaceutical makers also falsify or fudge the ‘science’ they supply to CDC,
FDA, and print on package inserts?
One thing I think that needs to be pointed out is the revolving door policy that apparently exists between federal government health agencies and Big Pharma. Julie Gerberding, MD, MPH, was the Director of the CDC during the 2006 mumps outbreak. Wasn’t she attributed with saying, “We have absolutely no information to suggest that there is any problem with the vaccine”? Again, this remark apparently reflects the CDC’s implicit reliance upon Big Pharma to produce the ‘science’, which definitely is a conflict of interest that FDA and Congress must fix. Oh by the way, Dr Gerberding is now President of Merck’s vaccine division.
According to the complaint, the plaintiffs pointed out that Emory University is conducting a clinical trial attempting to find the cause or explain the 2006 mumps outbreak in college-age students who received both doses of the vaccine. Please get this part: Merck is a collaborator on that study! In view of the whistleblowers’ lawsuit about the mumps vaccine, wouldn’t one think that Merck would not be wanted in the investigation?
Here is a statistic for vaccine safety advocates taken from the complaint:
Nearly 5,000 cases of mumps were confirmed during the 2009 outbreak.
So one can readily see that these outbreaks should not be blamed upon non-vaccinated children, since the very vaccinated children may be those contracting the diseases for which they were vaccinated. If anything, this lawsuit against Merck proves more in the vaccine safety advocates’ corner and puts vaccine makers’ pseudo science on the ropes, I’d say.
One interesting factoid I found in the complaint is how the 1986 vaccine law probably came about. Merck and the CDC were haggling about certain aspects of disclosing diminished efficacy and Merck made some suggestions in 1970 that CDC agreed to. It basically was this:
“It provided a way to assure that the CDC could purchase Merck’s vaccines without Merck being subjected to personal injury claims for failing to warn individual vaccinees or their parents about the safety and efficacy of vaccines administered through government vaccination programs.” [Complaint pg.32, clause 106]
As this writer interprets the above, the 1986 vaccine law Congress passed should be repealed as it represents the utmost of conflict of interest, special privilege, and a denial of tort rights to damaged individuals.
Perhaps members of Congress ought to read the current complaint filed against Merck, do an about face and retract/rescind The National Childhood Vaccine Injury Act (NCVIA) of 1986 (42 U.S.C. §§ 300)—the National Vaccine Injury Compensation Program. Such Congressional action would provide relief for infants and children damaged not only by Merck’s mumps-containing MMRII vaccine, but also for other vaccines that probably are fudged scientifically and by which Big Pharma makes jillions without being held responsible for damaging innocent children. Who will file a lawsuit for them?
Why didn’t the media and press report the 2010 complaint filed against Merck’s fraudulent mumps vaccine? Doesn’t a defective vaccine apparently impact public health according to the CDC and FDA belief system? Why wasn’t the public told of such vaccine fraud? Could such non-reporting of an apparent public health problem generated by an apparent fraudulent and defective vaccine be considered a conspiracy of silence on the part of the media, the press, and whoever is their muse? Isn’t it about time the U.S. healthcare consumer found out that it apparently cannot trust the CDC or FDA or Big Pharma when it comes to vaccines and vaccinations, the ‘Sacred Cow’ of modern medicine?